Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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THERAPY REHAB WEIGHTED BAR, YELLOW 9 LBS, 48" LENGTH
M J M International Corporation
TRWB-Y-48
In Commercial Distribution

  • 00849229006314 ()


  • Hand-held free weight exerciser
THERAPY REHAB WEIGHTED BAR, LILAC 8.5 LBS, 48" LENGTH
M J M International Corporation
TRWB-L-48
In Commercial Distribution

  • 00849229006307 ()


  • Hand-held free weight exerciser
THERAPY REHAB WEIGHTED BAR, ORANGE 8 LBS, 48" LENGTH
M J M International Corporation
TRWB-O-48
In Commercial Distribution

  • 00849229006291 ()


  • Hand-held free weight exerciser
THERAPY REHAB WEIGHTED BAR, GREEN 7.5 LBS, 48" LENGTH
M J M International Corporation
TRWB-G-48
In Commercial Distribution

  • 00849229006284 ()


  • Hand-held free weight exerciser
THERAPY REHAB WEIGHTED BAR, BLUE 7 LBS, 48" LENGTH
M J M International Corporation
TRWB-B-48
In Commercial Distribution

  • 00849229006277 ()


  • Hand-held free weight exerciser
THERAPY REHAB WEIGHTED BAR, WHITE 6.5 LBS, 48" LENGTH
M J M International Corporation
TRWB-W-48
In Commercial Distribution

  • 00849229006260 ()


  • Hand-held free weight exerciser
THERAPY REHAB WEIGHTED BAR, BROWN 6 LBS, 48" LENGTH
M J M International Corporation
TRWB-BRN-48
In Commercial Distribution

  • 00849229006253 ()


  • Hand-held free weight exerciser
THERAPY REHAB WEIGHTED BAR, BLACK 5.5 LBS, 42" LENGTH
M J M International Corporation
TRWB-BLK-42
In Commercial Distribution

  • 00849229006246 ()


  • Hand-held free weight exerciser
THERAPY REHAB WEIGHTED BAR, GRAY 5 LBS, 42" LENGTH
M J M International Corporation
TRWB-GRY-42
In Commercial Distribution

  • 00849229006239 ()


  • Hand-held free weight exerciser
THERAPY REHAB WEIGHTED BAR, RED 4.5 LBS, 36" LENGTH
M J M International Corporation
TRWB-R-36
In Commercial Distribution

  • 00849229006222 ()


  • Hand-held free weight exerciser
THERAPY REHAB WEIGHTED BAR, YELLOW 4 LBS, 36" LENGTH
M J M International Corporation
TRWB-Y-36
In Commercial Distribution

  • 00849229006215 ()


  • Hand-held free weight exerciser
THERAPY REHAB WEIGHTED BAR, LILAC 3.5 LBS, 36" LENGTH
M J M International Corporation
TRWB-L-36
In Commercial Distribution

  • 00849229006208 ()


  • Hand-held free weight exerciser
THERAPY REHAB WEIGHTED BAR, ORANGE 3 LBS, 36" LENGTH
M J M International Corporation
TRWB-O-36
In Commercial Distribution

  • 00849229006192 ()


  • Hand-held free weight exerciser
THERAPY REHAB WEIGHTED BAR, GREEN 2.5 LBS, 36" LENGTH
M J M International Corporation
TRWB-G-36
In Commercial Distribution

  • 00849229006185 ()


  • Hand-held free weight exerciser
THERAPY REHAB WEIGHTED BAR, BLUE 2 LBS, 36" LENGTH
M J M International Corporation
TRWB-B-36
In Commercial Distribution

  • 00849229006178 ()


  • Hand-held free weight exerciser
THERAPY REHAB WEIGHTED BAR, WHITE 1.5 LBS 36" LENGTH
M J M International Corporation
TRWB-W-36
In Commercial Distribution

  • 00849229006161 ()


  • Hand-held free weight exerciser
THERAPY REHAB WEIGHTED BAR, BROWN 1 LS, 36" LENGTH
M J M International Corporation
TRWB-BRN-36
In Commercial Distribution

  • 00849229006154 ()


  • Hand-held free weight exerciser
No Description
M J M International Corporation
920-R
In Commercial Distribution

  • 00849229003818 ()


  • Hospital stretcher, manual
No Description
M J M International Corporation
920-P
In Commercial Distribution

  • 00849229003801 ()


  • Hospital stretcher, manual
No Description
M J M International Corporation
920-MRI
In Commercial Distribution

  • 00849229003771 ()


  • Hospital stretcher, manual
No Description
M J M International Corporation
920
In Commercial Distribution

  • 00849229003740 ()


  • Hospital stretcher, manual
No Description
M J M International Corporation
910-DB
In Commercial Distribution

  • 00849229003733 ()


  • Hospital stretcher, manual
No Description
M J M International Corporation
910-B
In Commercial Distribution

  • 00849229003726 ()


  • Hospital stretcher, manual
No Description
M J M International Corporation
910-HS
In Commercial Distribution

  • 00849229001791 ()


  • Hospital stretcher, manual
WALKERS TO PROVIDE / PROMOTE PATIENT INDEPENDENCE; ALLOWS RESIDENTS TO AMBULATE SAFELY IN HEALTHCARE FACILITIES AND / OR PRIVATE HOMES
M J M International Corporation
WALKER
In Commercial Distribution

  • 00849229001371 ()


  • Handgrip disability-assistive walker, non-powered, non-foldable
No Description
M J M International Corporation
915
In Commercial Distribution

  • 00849229001357 ()


  • Hospital stretcher, manual
SHOWER CHAIR TO PROVIDE TRANSFERRING, BATHING AND / OR TOILETING FOR PATIENTS IN HEALTHCARE FACILITIES AND / OR PRIVATE HOMES
M J M International Corporation
SHOWER CHAIRS
In Commercial Distribution

  • 00897074002876 ()
100 SERIES

  • Washing/toileting non-lifting transfer chair
No Description
M J M International Corporation
910
In Commercial Distribution

  • 00897074002166 ()


  • Hospital stretcher, manual
VIROTROL EBV (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
00128B
In Commercial Distribution

  • 00847661005575 ()
00128B

  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin M (IgM) antibody IVD, control
  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, control
VIROTROL EBV (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
00128A
In Commercial Distribution

  • 00847661005568 ()
00128A

  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin M (IgM) antibody IVD, control
  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, control
VIROCLEAR EBV (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
00131
In Commercial Distribution

  • 00847661002727 ()
00131

  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin M (IgM) antibody IVD, control
  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, control
An in vitro diagnostic test for the detection of anti-Dengue IgM and/or IgG in human whole blood of dengue infected patient from acute to convalescent stage.
NANO-DITECH CORPORATION
MD8144
In Commercial Distribution

  • 00895160002489 ()
  • 10895160002486 ()
MD8144

  • Dengue virus immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, rapid ICT, clinical
An in vitro diagnostic test for the detection of Dengue NS1 protein in human whole blood of dengue infected patient from acute to convalescent stage.
NANO-DITECH CORPORATION
MD8143
Not in Commercial Distribution

  • 00895160002472 ()
  • 10895160002479 ()
MD8143

  • Dengue virus immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, rapid ICT, clinical
No Description
Bion Enterprises, Ltd.
CM-2012
In Commercial Distribution

  • B110CM20120 ()
CM-2012

  • Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, reagent
  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, reagent
Tinted Liquid
JBC and Company
M
In Commercial Distribution

  • D851M0 ()
M

  • Dental appliance fabrication material, resin
FITC Mounting Medium (pH 7.5), 3.0 mL
MARDX DIAGNOSTICS, INC.
90-1610
In Commercial Distribution

  • 05391516747943 ()
90-1610

  • Borrelia burgdorferi total antibody IVD, kit, immunoblot
  • Glomerular basement membrane antibody (Goodpasture antibody) IVD, kit, fluorescent immunoassay
  • Skeletal muscle antibody IVD, kit, fluorescent immunoassay
  • Trypanosoma cruzi immunoglobulin G (IgG)/IgM antibody IVD, kit, fluorescent immunoassay
  • Multiple Leishmania species immunoglobulin G (IgG)/IgM antibody IVD, kit, fluorescent immunoassay
No Description
Lgc Clinical Diagnostics, Inc.
2000-0102
In Commercial Distribution

  • 00850041090030 ()


  • Multiple infectious organism/newborn TORCH screen IVD, control
No Description
Lgc Clinical Diagnostics, Inc.
2015-0240
In Commercial Distribution

  • 00850041090023 ()


  • Multiple infectious organism/newborn TORCH screen IVD, control
No Description
Lgc Clinical Diagnostics, Inc.
2010-0023
In Commercial Distribution

  • 00850041090016 ()


  • Multiple infectious organism/newborn TORCH screen IVD, control
No Description
Lgc Clinical Diagnostics, Inc.
2000-0101
In Commercial Distribution

  • 00850041090009 ()


  • Multiple infectious organism/newborn TORCH screen IVD, control
VIROTROL ToRCH-M (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
00117B
In Commercial Distribution

  • 00847661005476 ()
00117B

  • Multiple infectious organism/newborn TORCH screen IVD, control
VIROTROL ToRCH Q (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
00230
In Commercial Distribution

  • 00847661005445 ()
00230

  • Multiple infectious organism/newborn TORCH screen IVD, control
VIROCLEAR ToRCH (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
00118
In Commercial Distribution

  • 00847661002642 ()
00118

  • Multiple infectious organism/newborn TORCH screen IVD, control
VIROTROL ToRCH (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
00109
In Commercial Distribution

  • 00847661002604 ()
00109

  • Multiple infectious organism/newborn TORCH screen IVD, control
Liquichek ToRCH Plus IgM Control, Negative MiniPak (A human serology IgM Control.)
BIO-RAD LABORATORIES, INC.
230NX
In Commercial Distribution

  • 00847661000518 ()
230NX

  • Multiple infectious organism/newborn TORCH screen IVD, control
Liquichek ToRCH Plus IgM Control, Positive MiniPak (A human serology IgM Control.)
BIO-RAD LABORATORIES, INC.
229PX
In Commercial Distribution

  • 00847661000501 ()
229PX

  • Multiple infectious organism/newborn TORCH screen IVD, control
Liquichek ToRCH Plus IgM Control, Negative (A human serology IgM Control.)
BIO-RAD LABORATORIES, INC.
230
In Commercial Distribution

  • 00847661000273 ()
230

  • Multiple infectious organism/newborn TORCH screen IVD, control
Liquichek ToRCH Plus IgM Control, Positive (A human serology IgM Control.)
BIO-RAD LABORATORIES, INC.
229
In Commercial Distribution

  • 00847661000266 ()
229

  • Multiple infectious organism/newborn TORCH screen IVD, control
ToRCH EBV Positive Control is intended for use with in vitro assays for determination of IgG and IgM antibodies to the viral capsid antigen of Epstein-Barr Virus (EBV VCA) and IgG antibodies to the viral polypeptide nuclear antigen of Epstein-Barr Virus (EBV EBNA). ToRCH EBV Positive Control is unassayed without target values and is suitable for use on many analysers. This control must not be used as a substitute for the mandatory manufacturer’s kit controls provided with the assay. ToRCH EBV Positive Control is helpful in determining the precision of testing systems and in identifying sources of variation.
RANDOX LABORATORIES LIMITED
SR10350
In Commercial Distribution

  • 05055273216431 ()
SR10350

  • Multiple infectious organism/newborn TORCH screen IVD, control
ToRCH IgM Positive Control is intended for use with in vitro assays for determination of IgM antibodies to Cytomegalovirus (CMV), IgM antibodies to Rubella Virus, IgM antibodies to Toxoplasma gondii, IgM antibodies to Herpes Simplex Virus Type 1 and 2. ToRCH IgM Positive Control is unassayed without target values and is suitable for use on many analysers. This control must not be used as a substitute for the mandatory manufacturer’s kit controls provided with the assay. ToRCH IgM Positive Control is helpful in determining the precision of testing systems and in identifying sources of variation.
RANDOX LABORATORIES LIMITED
SR10349
In Commercial Distribution

  • 05055273216424 ()
SR10349

  • Multiple infectious organism/newborn TORCH screen IVD, control
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